Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato. The application seeks to allow Spravato to be utilized as a standalone therapy for patients suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant, specifically targeting patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that many endure prolonged cycles of ineffective treatments, which impose significant emotional and functional burdens on both patients and their families.
The submission to the FDA includes findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was able to alleviate patients’ symptoms within 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.